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TMF Associate
AlimentivTMF Associate responsible for managing Trial Master Files and supporting clinical studies. Collaborating with cross-functional teams and ensuring compliance during the study lifecycle.
About the role
Key responsibilities & impact- Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up to transfer/archiving.
- Work in partnership with study teams during periodic file reviews and audits to address findings related to the TMF.
- Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework.
- Work proactively and successfully within a cross-functional team.
- Communicate and promote department and company goals and practices.
- Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude.
Requirements
What you’ll need- The successful candidate will possess a college diploma/degree and 1-3 years of relative related experience or on going training.
- They will have an understanding of TMF organization, implementation, and archival including relevant regulations and guidance to assure quality and integrity of TMFs.
- Have the ability to incorporate the principles of ALCOA in relation to TMF oversight.
- Utilize skills in time management and problem-solving.
- Identify challenges and problems and take the initiative to identify solutions.
- Demonstrated computer literacy, proven functional knowledge of Microsoft packages and potential to develop.
Benefits
Comp & perks- Home based, with the ability to go into office occasionally if needed.
- Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
TMF OrganizationTMF ImplementationTMF ArchivalRegulatory ComplianceFile Structure Management
Soft Skills
CommunicationTeam CollaborationPositive Attitude